MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) today
announced results from the phase 1b/2a clinical trial evaluating
its proprietary HuCAL antibody MOR103 in rheumatoid arthritis (RA)
patients. The positive data make MOR103 the first anti-GM-CSF
antibody to demonstrate clinical efficacy in RA. The results
demonstrate the compound's potential to become an important new
drug in an area of unmet medical need. MorphoSys will submit a
late-breaking abstract for a forthcoming conference to present the
clinical trial results before the end of the year.
"We are very excited by the results of the study," commented Dr.
Arndt Schottelius, Chief Development Officer of MorphoSys AG. "The
ACR20 score ranks amongst the highest seen for a biological
compound in RA after four weeks of treatment. The excellent
efficacy and safety data we observed underline MOR103's potential
to become a first-in-class treatment modality for RA patients, with
a novel and differentiated mechanism of action. We expect to
present the data at the most relevant medical conference for RA
later this year. The quality of the data demonstrates the
capabilities of our discovery and development organization and mark
a significant step in MorphoSys's strategy to bring innovative
drugs to patients."
The best response was achieved in the 1.0 mg/kg dose cohort with an
ACR20 score of 68% at week 4, which was significantly higher than
in the control arm (p<0.0001). Of particular importance was the
fast onset of action observed: within 2 weeks, up to 40% of
patients achieved an ACR20 score. Improvement of DAS28 scores was
rapid and significant over the treatment period of the study. MRI
scans revealed a reduction of synovitis according to the RAMRIS
system at week 4.
MOR103 was safe and well-tolerated at all doses administered. There
were no drug-related serious adverse events. No obvious differences
in the adverse event rate between the MOR103 and placebo groups
were observed.
"These are excellent results," commented the principal investigator
of the study, Professor Harald Burkhardt, Professor of Rheumatology
and Head of the Division of Rheumatology at Frankfurt University.
"Considering the short first-in-patient study, MOR103 demonstrated
very promising clinical activity and fast onset of action with
favorable safety data."
In the randomized, double-blind, placebo-controlled phase 1b/2a
trial in 96 mild to moderate RA patients, MOR103 was administered
in four weekly doses of 0.3 mg/kg, 1.0 mg/kg or 1.5 mg/kg. The
trial, which was designed to look in particular at the onset of the
therapeutic effect, was conducted in 26 centers in Germany,
Netherlands, Poland, Bulgaria and Ukraine. The majority of the
trial participants were on a stable regimen of disease modifying
anti-rheumatic drugs. The primary endpoint of the trial was to
determine the safety and tolerability of multiple doses of MOR103
in patients with active RA. Secondary outcome measures were
pharmacokinetics, immunogenicity, and the drug's potential to
improve clinical signs and symptoms of RA as measured by DAS28,
ACR20/50/70 and EULAR response criteria, MRI imaging for synovitis
and bone edema as well as patient reported outcomes.
Based on these compelling data, MorphoSys will now proceed with its
plans to seek a commercial partner for further development of the
program. In addition to the RA study, MOR103 is currently being
evaluated in a phase 1b dose-escalation study in multiple
sclerosis. Results of a phase 1 pharmacokinetic study in healthy
volunteers to evaluate a subcutaneous formulation of MOR103 will be
available shortly.
Overview of Study Results:
Results at day 28
(Majority of patients were on stable regimen of DMARDS) Placebo
MOR103 [0.3 mg/kg] MOR103 [1.0 mg/kg] MOR103 [1.5 mg/kg]
Number of patients 27 24 22 23
Proportion of patients achieving ACR20 7% 25% 68% 30%
Proportion of patients achieving ACR50 4% 4% 23% 9%

Please dial in 10 minutes before the beginning of the
conference.
In addition, MorphoSys offers participants the opportunity to
follow the presentation through a simultaneous slide presentation
online at http://www.morphosys.com/conference-calls.
A live webcast, slides, webcast replay and transcript will be made
available at http://www.morphosys.com/conference-calls.

About MOR103:
MOR103 is a fully human antibody against GM-CSF (granulocyte
macrophage-colony stimulating factor). GM-CSF was originally
identified as a growth factor for granulocytes and macrophages but
has more recently been identified as an inflammatory mediator in
autoimmune disorders such as RA. GM-CSF stimulates stem cells to
produce granulocytes and other macrophages and subsequently
activates these differentiated immune cells leading to an increased
production of pro-inflammatory cytokines, chemokines and proteases
and thereby ultimately to articular destruction. The antibody
MOR103 blocks GM-CSF and reduces its pro-inflammatory
activity.

About clinical trials in RA:
Rheumatoid arthritis, or RA for short, is traditionally considered
a chronic, inflammatory autoimmune disorder that causes the immune
system to attack the joints and affects in particular a membrane,
called synovium, which lines each movable joint. It is a disabling
and painful inflammatory condition, which can lead to substantial
loss of mobility due to pain and joint destruction. The disease
affects approximately 4-6 million people worldwide. To analyze the
effect of a compound in a clinical trial in RA, disease scores such
as ACR- a measure summarizing improvement in the number of tender
and swollen joints, pain scale, patients' and physicians'
assessment of improvement and certain laboratory markers - and
DAS28 scores are used. ACR 20 describes the percentage of study
participants who achieved a 20 percent improvement in tender or
swollen joint counts as well as 20 percent improvement in three
other disease-relevant criteria. For the DAS28 score 28 swollen
joints and 28 tender joints are assessed.

About MorphoSys:
MorphoSys developed HuCAL, the most successful antibody library
technology in the pharmaceutical industry. By successfully applying
this and other patented technologies, MorphoSys has become a leader
in the field of therapeutic antibodies, one of the fastest-growing
drug classes in human healthcare. The company's AbD Serotec unit
uses HuCAL and other antibody technologies to generate superior
monoclonal antibodies for research and diagnostic
applications.
Together with its pharmaceutical partners, MorphoSys has built a
therapeutic pipeline of more than 70 human antibody drug candidates
for the treatment of cancer, rheumatoid arthritis, and Alzheimer's
disease, to name just a few. With its ongoing commitment to new
antibody technology and drug development, MorphoSys is focused on
making the healthcare products of tomorrow. MorphoSys is listed on
the Frankfurt Stock Exchange under the symbol MOR. For regular
updates about MorphoSys, visit http://www.morphosys.com

This communication contains certain forward-looking statements
concerning the MorphoSys group of companies. The forward-looking
statements contained herein represent the judgment of MorphoSys as
of the date of this release and involve risks and uncertainties.
Should actual conditions differ from the Company's assumptions,
actual results and actions may differ from those anticipated.
MorphoSys does not intend to update any of these forward-looking
statements as far as the wording of the relevant press release is
concerned.

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